BACKGROUND: Positive inotropic agents may be associated with increasing myocardial ischemia or malignant arrhythmias. Levosimendan, a new calcium sensitizer, with its little effect on myocardial oxygen demand is better tolerated by patients with acute coronary syndromes. We evaluated the acute effects of levosimendan on hemodynamics and coronary flow velocities in patients with left ventricular (LV) dysfunction undergoing percutaneous coronary interventions (PCIs) for an acute myocardial infarction (AMI). METHODS:Patients with AMI and LV dysfunction undergoing primary PCI were randomized to intravenous infusion of levosimendan (10 minutes bolus with 12 microg/kg followed by 0.1 microg/kg per minute for 24 hours) or placebo, 10 minutes after a primary PCI. Evaluation of hemodynamics and of coronary flow reserve (CFR) were performed at baseline and after bolus. RESULTS:Twenty-six consecutive patients (mean age 57 +/- 5.4 years, 18 males) were included into the study. At baseline, mean values of hemodynamics and coronary flow velocities were comparable between groups. After bolus, patients with levosimendan (n = 12) showed a significant decrease of pulmonary capillary wedge pressure (from 24 to 19 mm Hg) and a significant increase of cardiac index (from 1.8 to 2.4 L/m2 per minute) resulting in a significant decrease of systemic vascular resistance (from 1366 to 1075 [dyne . s]/cm2). Moreover, CFR on infarct-related artery and on reference vessel significantly improved in patients treated with levosimendan (from 1.6 to 2.0 and from 2.1 to 2.4, respectively). On the other hand, no statistically significant changes have been observed in the placebo group (n = 14). CONCLUSIONS:Levosimendan, given intravenously after a PCI procedure in patients with AMI and LV dysfunction, significantly improves hemodynamics and CFR, compared with placebo.
RCT Entities:
BACKGROUND: Positive inotropic agents may be associated with increasing myocardial ischemia or malignant arrhythmias. Levosimendan, a new calcium sensitizer, with its little effect on myocardial oxygen demand is better tolerated by patients with acute coronary syndromes. We evaluated the acute effects of levosimendan on hemodynamics and coronary flow velocities in patients with left ventricular (LV) dysfunction undergoing percutaneous coronary interventions (PCIs) for an acute myocardial infarction (AMI). METHODS:Patients with AMI and LV dysfunction undergoing primary PCI were randomized to intravenous infusion of levosimendan (10 minutes bolus with 12 microg/kg followed by 0.1 microg/kg per minute for 24 hours) or placebo, 10 minutes after a primary PCI. Evaluation of hemodynamics and of coronary flow reserve (CFR) were performed at baseline and after bolus. RESULTS: Twenty-six consecutive patients (mean age 57 +/- 5.4 years, 18 males) were included into the study. At baseline, mean values of hemodynamics and coronary flow velocities were comparable between groups. After bolus, patients with levosimendan (n = 12) showed a significant decrease of pulmonary capillary wedge pressure (from 24 to 19 mm Hg) and a significant increase of cardiac index (from 1.8 to 2.4 L/m2 per minute) resulting in a significant decrease of systemic vascular resistance (from 1366 to 1075 [dyne . s]/cm2). Moreover, CFR on infarct-related artery and on reference vessel significantly improved in patients treated with levosimendan (from 1.6 to 2.0 and from 2.1 to 2.4, respectively). On the other hand, no statistically significant changes have been observed in the placebo group (n = 14). CONCLUSIONS:Levosimendan, given intravenously after a PCI procedure in patients with AMI and LV dysfunction, significantly improves hemodynamics and CFR, compared with placebo.